|RxNews Recap for Wednesday 03-03-10. Dendreon and Santarus surge after the bell.|
|By BioMedReports.com Staff|
|Wednesday, 03 March 2010 19:16|
Dendreon Corporation (Nasdaq:DNDN) saw its shares leap after hours as the company announced updated results from its pivotal Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study demonstrating that PROVENGE® (sipuleucel-T) extends overall survival in men with metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). The data will be presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco on Friday, March 5 at 1:45 pm PT.
A sensitivity analysis performed with longer-term follow-up (36.5 months) and additional events (349 deaths) collected at the time of study closure demonstrated that PROVENGE increased three-year survival by 40 percent compared to placebo (32.1 percent vs 23.0 percent), the median survival difference of PROVENGE compared to placebo was maintained at 4.1 months, with a 24.1 percent reduction in the risk of death [HR=0.759] and a p-value of 0.017.
As previously reported in a primary analysis (34.1 months median follow-up; 331 deaths), the IMPACT study met its pre-specified primary endpoint of significantly improving overall survival compared to placebo, demonstrating that PROVENGE increased three-year survival by 38 percent compared to placebo (31.7 percent vs 23.0 percent), extending median survival by 4.1 months compared to placebo (25.8 months vs. 21.7 months), with a 22.5 percent reduction in the risk of death [HR=0.775] and a p-value of 0.032.
In addition, new analyses demonstrated that the median predicted survival of the two treatment arms using the Halabi model were well balanced (20.3 months for PROVENGE vs 21.2 months for placebo). Furthermore, in an analysis in which patients were censored at the time of docetaxel use, the PROVENGE treatment effect remained strong [HR=0.649].
DNDN was up $1.36 to $34.98 in the after hours market.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, shot up after hours when the company reported financial and operating results for the quarter and full year ended December 31, 2009.
Key financial results for the 2009 fourth quarter: *Product-related revenue of $38.9 million compared with $34.8 million for the prior year period. * Total revenues of $62.4 million compared with 2008 fourth quarter total revenues of $37.5 million. * Net income of $24.5 million, or $0.40 per diluted share, compared with a net loss of $10.2 million, or $0.19 per share, in the fourth quarter of 2008.* Total revenues and net income reflected the positive impact of a $20 million milestone earned in December 2009 related to the U.S. Food and Drug Administration (FDA) approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules).
Key financial results for the 2009 full year: * Product-related revenue of $142.9 million increased 29% compared with $111.0 million in the prior year.* Total revenues of $172.5 million increased 32% compared with 2008 total revenues of $130.2 million. * Net income of $32.1 million, or $0.54 per diluted share, compared with a net loss of $18.5 million, or $0.36 per share, in 2008.* Positive cash flow from operations of $37.0 million. * Cash, cash equivalents and short-term investments of $93.9 million as of December 31, 2009.
"We are pleased to report our first full year of profitability," said Debra P. Crawford, senior vice president and chief financial officer of Santarus. "We grew 2009 product-related revenue by 29%, while reducing total costs and expenses by 7% compared with the prior year. Our strong operating results were further enhanced by the $20 million milestone relating to FDA approval of ZEGERID OTC."
Shares of Santarus traded higher by 30 cents or 6.82% in the after hours session.
In news from earlier in the day:
Abbott (NYSE:ABT) announced today that it has entered into an agreement with GlaxoSmithKline (GSK) to develop a molecular diagnostic test intended for use as an aid in selecting patients who may benefit from a skin cancer treatment in development by GSK.
Interleukin Genetics, Inc. (NYSE Amex: ILI) announced presentation of findings from a retrospective clinical study on weight management conducted in collaboration with Stanford University. The study results and conclusions were presented today by investigators from Stanford Prevention Research Center at Stanford University School of Medicine during an oral presentation titled "Genotype Patterns Predict Weight Loss Success: The Right Diet Does Matter," at the American Heart Association's Joint 50th Cardiovascular Disease Epidemiology and Prevention – and – Nutrition, Physical Activity and Metabolism conference, being held March 2-5 in San Francisco, CA.
MedPro Safety Products, Inc. (OTCBB: MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection system, announced today that it will present at the Cowen and Company 30th Annual Health Care Conference on Monday, March 8, 2010 at The Boston Marriott Copley Place in Boston, Massachusetts.
"The successful audit of our manufacturing facility by the Israeli Health Ministry is another important milestone toward our plans to commercialize taliglucerase alfa in Israel and throughout the world," said Dr. David Aviezer, President and CEO of Protalix. "This important achievement helps to demonstrate the viability, quality and commercial potential of our proprietary plant-cell based technology platform."
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA) (FF:PV3), a leader in the development of ophthalmic sustained release drug delivery products, with two of the only three such products approved by the FDA for treatment of back of the eye diseases, today said that 24-month data from the FAME Phase 3 study for Iluvien presented at Angiogenesis 2010 included additional efficacy and safety data that reinforced the positive top-line results reported in December 2009 by pSivida and its licensee, Alimera Sciences, Inc.
PTC Therapeutics, Inc. and Genzyme Corporation (Nasdaq: GENZ) today announced preliminary results from the Phase 2b clinical trial of ataluren, an investigational new drug, in patients with nonsense mutation Duchenne/Becker Muscular Dystrophy (nmDBMD).
Repligen Corporation (Nasdaq:RGEN) announced today that it has acquired the assets of BioFlash Partners, LLC, (BioFlash) including a technology platform for the production of pre-packed, "plug and play" chromatography columns. This patented technology enables economical production of chromatography columns in a format that is ready for use in the production of a broad range of biopharmaceuticals including monoclonal antibodies, vaccines and recombinant proteins. The terms of the acquisition include an upfront payment of $1.8 million, a contingent milestone and royalties based on product sales. A product offering based on this technology is being launched this week at the IBC Biopharmaceutical Development and Production conference under the brand name Opus(TM). The global market for chromatography media used in the production of biopharmaceuticals is estimated to be approximately $500 million.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today reported financial and operating results for the quarter and full year ended December 31, 2009.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, president and chief executive officer, will present at the 30th Annual Cowen and Company Healthcare Conference being held at the Boston Marriott Copley Place in Boston, Mass.
Transition Therapeutics Inc. (TSX:TTH) (Nasdaq:TTHI) rose today after the company announced that it has acquired the rights to a series of preclinical compounds from Eli Lilly and Company in the area of diabetes. Under the licensing and collaboration agreement, Transition will receive exclusive worldwide rights to develop and potentially commercialize a class of compounds that, in preclinical diabetes models showed potential to provide glycemic control and other beneficial effects including weight loss.
"We are very pleased to expand our current relationship with Lilly through the acquisition of these preclinical assets," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition. "The addition of these novel compounds leverages our expertise in metabolic diseases and grows our development pipeline with next generation diabetes therapies."
Urigen Pharmaceuticals, Inc. (OTCBB: URGP), a specialty pharmaceutical company focused on the development of treatments for urological disorders and pain, announced today that Edward R. Teitel, MD, JD has been elected Chairman of the Board of Directors.
Uroplasty, Inc. (NYSE Amex: UPI) highlighted results from a two-year, multicenter clinical study of Macroplastique that will be published in the April 2010 print edition of The Journal of Urology(R). The 24-month study evaluated the durability of Macroplastique for stress urinary incontinence in women with previously documented success at 12 months. Substantial, durable results were sustained during 2 years with 84% of patients maintaining significant improvement from their 12-month assessment. Additionally, 67% of the patients implanted with Macroplastique were dry at the 24-month follow-up visit.
VIVUS, Inc. (Nasdaq: VVUS) today announced that Timothy Morris, Chief Financial Officer, will present an overview of the company at two inventment conferences during the month of March.
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